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0001
1 UNITED STATES DEPARTMENT OF JUSTICE
2 DRUG ENFORCEMENT ADMINISTRATION
3
- - - - - - - - - - - - - - - x
4 :
In the Matter of: :
5 :
LYLE E. CRAKER, Ph.D. : Docket No. 05-16
6 :
- - - - - - - - - - - - - - - x
7
VOLUME 8
8
9 Wednesday, December 14, 2005
10 DEA Headquarters
11 600 Army Navy Drive
12 Hearing Room E-2103
13 Arlington, Virginia
14
15 The hearing in the above-entitled matter
16
17 convened, pursuant to notice, at 9:06 a.m.
18
19 BEFORE:
20
21 MARY ELLEN BITTNER
22 Chief Administrative Law Judge
0002
1 APPEARANCES:
2 On Behalf of the DEA:
3 BRIAN BAYLY, ESQ.
Office of Chief Counsel
4 Drug Enforcement Administration
Washington, D.C. 20537
5
IMELDA L. PAREDES, ESQ.
6 Senior Attorney
Office of Chief Counsel
7 (202) 353-9676
8
On Behalf of the Respondent:
9
JULIE M. CARPENTER, ESQ.
10 Jenner & Block LLP
601 13th Street, N.W.
11 Suite 1200 South
Washington, D.C. 20005
12 (202) 661-4810
13 M. ALLEN HOPPER, ESQ.
Senior Staff Attorney
14 Drug Reform Project
American Civil Liberties Union Foundation
15 1101 Pacific Avenue, Suite 333
Santa Cruz, California 95060
16 (831) 471-9000 Ext. 14
17 ALSO PRESENT:
18 MATTHEW STRAIT
19 Representative of the Government
20
21 RICHARD DOBLIN, Ph.D.
22 Representative of Respondent
0003
1 C O N T E N T S
2 WITNESS DIRECT CROSS REDIRECT RECROSS
3 Steven W. Gust 5 23 120 125
4
- - -
5
E X H I B I T S
6
EXHIBIT NOS. MARKED RECEIVED
7
GOVERNMENT'S
8
No. 24 -- 11
9 No. 34 -- 73
No. 4 -- 143
10 No. 26 -- 147
No. 27 -- 148
11 No. 31 -- 151
No. 32 -- 152
12 No. 33 -- 153
No. 35 -- 155
13 No. 44 -- 159
No. 45 -- 160
14 No. 47 -- 163
No. 49 -- 164
15 No. 52 -- 165
No. 55 -- 171
16 No. 62 -- 173
No. 64 -- 178
17 No. 82 -- 179
No. 83 -- 180
18 No. 84 -- 181
Nos. 92 and 92A -- 184
19
20 RESPONDENT'S
21
22 none
0004
1 P R O C E E D I N G S
2 JUDGE BITTNER: On the record. Mr. Bayly?
3 MR. BAYLY: We are going to call Dr. Steve
4 Gust, and we can get him done, and then talk about
5 scheduling for tomorrow.
6 I guess I should let you know, Judge
7 Bittner, and respondent's counsels, I think I may
8 have mentioned yesterday that Dr. Auslander, his
9 train is supposed to come in at 9:45.
10 JUDGE BITTNER: Tomorrow.
11 MR. BAYLY: Tomorrow.
12 JUDGE BITTNER: In the sleet?
13 MR. BAYLY: Well, and Amtrak, from my
14 experience, is not good in inclement weather, so we
15 could start in the morning perhaps, or go through
16 the exhibits, or maybe this afternoon, whatever the
17 Court and respondent's counsels prefer is okay with
18 me, but we may be starting fairly late in the
19 morning with Dr. Auslander.
20 That said, his testimony will be I think
21 the shortest by far definitely of all the
22 witnesses, so there isn't any question that we'll
0005
1 get done with him thursday. The question is when
2 we'll start with him.
3 JUDGE BITTNER: Well, let's see what
4 happens today and then we'll sort it out.
5 So are you ready to call Dr. Gust?
6 MS. PAREDES: Yes, Your Honor. The
7 government's going to call Dr. Steven Gust.
8 JUDGE BITTNER: If you would please come
9 right up here. Good morning. And if you would
10 stand and raise your right hand.
11 Whereupon,
12 STEVEN W. GUST
13 was called as a witness herein, and having been
14 duly sworn, was examined and testified as follows:
15 DIRECT EXAMINATION
16 BY MS. PAREDES:
17 Q Good morning, sir. Would you please state
18 your name, spelling your last?
19 A Steven W. Gust, G-u-s-t.
20 JUDGE BITTNER: And would you spell your
21 first name too, please?
22 THE WITNESS: Steven with a V.
0006
1 JUDGE BITTNER: Thank you.
2 BY MS. PAREDES:
3 Q And your highest level of education?
4 A Ph.D.
5 Q And, Dr. Gust, what is your current
6 position with the Federal Government?
7 A I'm Special Assistant to the Director at
8 the National Institute on Drug Abuse.
9 Q And would that commonly be referred to as
10 NIDA?
11 A Yes, NIDA.
12 Q And how long have you held this position?
13 A Since 1990.
14 Q Could you please explain where NIDA fits
15 within the structure of the Department of Health
16 and Human Services?
17 A Sure. The Department of Health and Human
18 Services has several large agencies, including the
19 FDA and the NIH, the National Institutes of Health.
20 There are 27, I think, at last count, separate
21 institutes and centers within--that comprise the
22 NIH as a whole, and NIDA is one of those 27.
0007
1 Q So can you explain then where's the
2 relationship between NIDA and NIH?
3 A NIDA is one of the components of NIH.
4 Q Can you explain what NIDA's mission is?
5 A NIDA's mission is to support research on
6 the causes, consequences, prevention and treatment
7 of drug abuse and drug addiction.
8 Q Does it also administer the National Drug
9 Supply Program?
10 A Yes, it does.
11 Q Can you explain how NIDA administers that
12 program?
13 A Well, the National Drug Supply Program
14 provides research materials to researchers. These
15 tend to be scheduled drugs, scheduled substances or
16 their precursors. In general that's it. Do you
17 want me to go into details about how it works or--
18 Q No. When you say scheduled drugs, do you
19 mean Schedules I through V, or just Schedule I?
20 A Yeah. Pretty much all scheduled drugs and
21 some nonscheduled drugs as well.
22 JUDGE BITTNER: But scheduling, referring
0008
1 to Federal schedule--
2 THE WITNESS: --under the Controlled
3 Substances Act, yes.
4 BY MS. PAREDES:
5 Q Can you explain the process by which NIDA
6 distributes marijuana?
7 A Requests for marijuana for research come
8 to NIDA, to our Drug Supply Program, at which point
9 there are three things that need to happen. First
10 of all, there needs to be a peer review for
11 scientific merit of the research proposal.
12 Secondly, there needs to be a registration with the
13 Drug Enforcement Agency. And thirdly, there needs
14 to be investigational new drug application filed
15 with the FDA.
16 Once those three things have occurred,
17 there is an ordering process where an investigator
18 submits an order form--I believe it's a DEA form--to NIDA,
19 and the order's filled.
20 Q Now, that process that you just described,
21 does that apply to all requests for marijuana
22 regardless of funding?
0009
1 A Yes, it does.
2 Q Now, are those three requirements unique
3 to specifically marijuana researchers or does that
4 apply across the board?
5 A It applies across the board for any
6 substances that are provided by NIDA to the Drug
7 Supply Program.
8 Q Now, I want to point your attention to the
9 peer review for scientific merit. When you use the
10 term "peer review," what are you referring to?
11 A Peer review is a process that has been
12 used, certainly by NIH, and I think in other
13 agencies in Department of Health and Human
14 Services, and probably the Federal Government,
15 where outside expertise is acquired and outside
16 opinions on the scientific merit of specific
17 research proposals.
18 Q When you refer to outside expertise, are
19 you referring to outside NIH or outside HHS, or
20 what exactly are you referring to?
21 A For the most part it's outside government.
22 The NIH system is the one I'm most familiar with,
0010
1 and there are established peer review committees
2 that are set up that review proposals three times a
3 year for the NIH, and there are--occasionally a
4 Federal employee participates in one of those
5 reviews, but probably 90 percent or more of the
6 participants are researchers who are in the private
7 sector, for the most part in academic institutions.
8 MS. PAREDES: I'd like the witness to be
9 shown what's been marked as Government Exhibit 24.
10 It has not been admitted yet.
11 MR. BAYLY: May I approach, Your Honor?
12 JUDGE BITTNER: Yes.
13 MS. PAREDES: I'll state for the record
14 that Government Exhibit 24 that has been handed to
15 the witness, does have some highlights in it, and
16 that was unintentional.
17 JUDGE BITTNER: I'm sorry? It has some
18 highlights in it and?
19 MS. PAREDES: It was unintentional.
20 JUDGE BITTNER: Okay. You not offering
21 the highlights.
22 MS. PAREDES: Correct.
0011
1 BY MS. PAREDES:
2 Q Dr. Gust, do you recognize this document?
3 A Yes.
4 Q Can you describe what it is?
5 A This is an announcement that was made in
6 1999 of the Department of Health and Human Services
7 policies and procedures regarding providing
8 marijuana for research on medical, to medical
9 aspects or medical uses of marijuana.
10 Q And to your knowledge, has this document
11 or this policy contained within this document,
12 hasn't been changed or altered since May 21st,
13 1999?
14 A No.
15 MS. PAREDES: Your Honor, the government
16 offers Government Exhibit 24 into evidence.
17 MR. HOPPER: No objection.
18 JUDGE BITTNER: Received.
19 [Government's Exhibit No. 24
20 received in evidence.]
21 BY MS. PAREDES:
22 Q Dr. Gust, would you explain what was the
0012
1 necessary peer review for medical marijuana
2 researchers before May 21st, 1999, when this
3 exhibit was published?
4 A The peer review was provided through one
5 of two means. First of all, if a researcher was
6 requesting government funding, that is, through NIH
7 or--through NIH, the peer review would be provided
8 by one of the standing peer review committees at
9 NIH. If the researcher had other sources of
10 funding, NIDA would, the normal course of events,
11 get outside experts, generally two or three outside
12 experts, to do an ad hoc review of the scientific
13 merit of the proposal.
14 Q With regard to the scientific merit of the
15 proposal, are you familiar with the pre-1999
16 guidance?
17 A Well, in general, I think the review
18 criteria--is that what you're asking me about?
19 Q Yes.
20 A In terms of--they may have changed
21 somewhat over the years, but in general there are
22 several kind of criteria that are used. First of
0013
1 all, the significance of the project, what's the
2 scientific significance? Is it going to advance
3 scientific knowledge? The approach, what is the
4 particular approach that the researchers are using?
5 Is it a valid approach? Is it one that's going to
6 provide the data that the researcher thinks it's
7 going to provide? Innovativeness, I think, is
8 another criterion. Is the research new and
9 different, or is it repeating something that's been
10 done in the past? The quality and qualifications
11 of the investigators are also part of the review
12 criterion, and also the research environment,
13 whether or not the facilities themselves are
14 adequate for conducting the proposed research.
15 In addition, researchers also have to
16 provide evidence that their proposals have been
17 reviewed and approved for human subjects' concerns
18 and issues, which tends to be a university based
19 process, but they have to provide evidence that
20 there are no human subjects' issues. And I think
21 that those criterion have been pretty much the same
22 pre and post 1999. There may have been a few
0014
1 little modifications over the years, but in general
2 that's what they are.
3 Q Now, the pre-1999 process that you've just
4 described, did that apply to other controlled
5 substances as well as marijuana?
6 A Yes.
7 Q Now, would you explain what this
8 Government Exhibit 24, what this implemented as far
9 as the medical marijuana research from the National
10 Drug Supply?
11 A I'm sorry. I missed part of your
12 question.
13 Q Would you explain what this document,
14 Government Exhibit 24, what this changed in terms
15 of the National Drug Supply Program?
16 A Right. It was about this time when there
17 was some increased interest in research, in
18 pursuing the medical use of marijuana, and in an
19 effort to make the process more standardized, and
20 to basically provide some expertise that did not
21 really exist at NIDA in terms of reviewing
22 applications that involved primarily the use of
0015
1 marijuana or any other substance for that matter
2 for treatment of diseases, which did not really
3 fall within NIDA's mission, the department
4 established a separate peer review process that
5 made the review--that moved the review into the
6 Public Health Service at the time where additional
7 expertise from other NIH Institutes and other
8 Federal agencies could be brought to bear to help--and help
9 provide reviews, appropriate reviews, of
10 the scientific merit of these applications.
11 I believe the other thing that this policy
12 changed was there was a provision that the
13 marijuana wouldn't be provided on a cost-reimbursable basis,
14 in other words, that marijuana
15 provided to projects that were outside of the NIH
16 system would need to reimburse the NIDA contractor
17 for the cost of the marijuana.
18 Q Dr. Gust, are you aware of where the
19 Public Health Service falls within the Department
20 of Health and Human Services structure?
21 A At the time it was a separate agency of
22 the Department of Health and Human Services, and
0016
1 since that time I believe it's been subsumed into
2 the Office of the Secretary of the Department of
3 Health and Human Services.
4 Q To your knowledge, is the Public Health
5 Service--what is the relationship of the Public
6 Health Service to NIDA?
7 A It's--the Public Health Service is part of
8 the direct Office of the Secretary of the
9 Department of Health and Human Services, and so
10 NIDA is, I guess you'd say, several levels below
11 that in the hierarchy of the department.
12 Q With regard to Government Exhibit No. 24,
13 does this policy change apply to the request for
14 marijuana in all research, or does it limit the
15 circumstances in which cases will be referred to
16 the PHS committee?
17 A It really applies just to applications to
18 do research on medical applications of marijuana in
19 human patients, or research that would be relevant
20 to the application--or relevant to the use of
21 marijuana in a medical application.
22 So what it excludes are sort of basic
0017
1 research studies, some animal research, for
2 example, or research in normal human volunteers,
3 that is, healthy human volunteers looking at other
4 aspects of the effects of marijuana, such as
5 effects on performance and memory and so forth and
6 so on. Those would not go to the PHS committee.
7 Q Would those types of projects be otherwise
8 reviewed?
9 A Absolutely. We would all get a peer
10 review--either through the NIH peer review system
11 or through the still-existing ad hoc system that
12 NIDA does use for the occasional application that
13 comes in that does not have Federal--that has
14 funding other than a Federal source, but is not
15 medical marijuana research.
16 Q Also, Dr Gust, in the administration of
17 your duties with NIDA, you also oversee the NIDA
18 contract with University of Mississippi?
19 A Yes.
20 Q Do you know when NIDA began privately
21 contracting cultivation of marijuana?
22 A To my knowledge, NIDA actually inherited
0018
1 the contract to provide the provision of marijuana
2 from an agency that predated NIDA's existence, so
3 that we have had this contract since NIDA's
4 inception in 1973 or '74.
5 Q And generally are you familiar with the
6 requirements of the contract?
7 A Yes.
8 Q To your knowledge, since you've been with
9 NIDA in 1990, have these requirements always been
10 similar?
11 A Yes.
12 Q Are you familiar with the process by which
13 the contract is awarded?
14 A In general, yes.
15 Q Can you explain what, in general terms,
16 how the contract is awarded?
17 A There's a statement of work that's
18 developed by the program staff, actually, myself
19 and Dr. Hari Singh are the two principals involved
20 in that, and other NIDA staff. Basically draft a
21 statement of work which outlines the work that
22 needs to be accomplished. That statement of work
0019
1 is then put into a request for proposal, and
2 submitted to our Contracts Procurement Office,
3 which announces the availability of this contract,
4 receives applications, conducts the review.
5 There's also a review done of all contract
6 proposals, as well as grant proposals. The
7 contracts are rated on criteria similar to what
8 research grants are. They're a little bit
9 different.
10 The review is conducted by a group, again,
11 of outside experts, and applications and applicants
12 that are reviewed within the technically acceptable
13 range are then reviewed on cost, and all
14 applications that are deemed technically acceptable
15 and within the cost estimates are negotiated with
16 by the Contracts Office, and then the application
17 for the proposal that has the best cost--or the
18 lowest cost and the best technical scores are
19 awarded the contract.
20 Q Now, Dr. Gust, are you personally involved
21 in selecting the winner, so to speak, of the
22 contract?
0020
1 A No, that's done by the Contracts Office.
2 Q Is there a contract in place today?
3 A Yes, there is.
4 Q And you're familiar with who won that
5 contract?
6 A Yes.
7 Q Do you know when it was awarded?
8 A March of 2005.
9 Q Was the process to award the contract in
10 place today, was that process followed as you've
11 just described?
12 A Yes.
13 Q Do you know where the contract was
14 advertised?
15 A I believe it was advertised in Commerce
16 Business Daily, and is it Federal Business Ops, Fed
17 Bus Ops.
18 Q Now, are you aware of Dr. Lyle Craker of
19 the University of Massachusetts?
20 A Yes.
21 Q Do you recall how you're aware of him?
22 A I believe I became aware of Dr. Craker at
0021
1 the time of one of his filings with the DEA?
2 Q How was it that it came to your knowledge?
3 A I believe I was contacted by the DEA.
4 Q And have you ever had any direct contact
5 with Dr. Craker?
6 A Not personally, no.
7 Q And otherwise have you had any contact
8 with him?
9 A Only indirectly through requesting that he
10 be notified of the last competition for this
11 contract.
12 Q And would you explain what you did in
13 regards to notifying Dr. Craker?
14 A I asked our Contracts Office to send Dr.
15 Craker the information on the notice in the Fed Bus
16 Ops, that this contract was available.
17 Q And to your knowledge, was that sent to
18 Dr. Craker?
19 A Yes.
20 Q Let's turn our attention now to NIDA's
21 receipt of complaints regarding marijuana. Have
22 you, are you aware of any time or any instance that
0022
1 NIDA received a complaint from qualified
2 researchers, doctors or patients about the quality
3 of the marijuana?
4 A Only what I've read in the papers. I am
5 not aware of any formal written complaints.
6 Q And has anyone, any researchers, doctors
7 or patients, ever called you by telephone to notify
8 you of any complaints?
9 A Not to my recollection, no.
10 MS. PAREDES: May I just have a moment,
11 please?
12 JUDGE BITTNER: Yes.
13 [Pause.]
14 MS. PAREDES: Nothing further, Your Honor.
15 JUDGE BITTNER: Mr. Hopper.
16 MR. HOPPER: May we have a few minutes,
17 Your Honor, to confer, say 10 minutes?
18 JUDGE BITTNER: Okay. Off the record, 10
19 minutes.
20 [Recess at 9:29 a.m.]
21 JUDGE BITTNER: On the record. Mr.
22 Hopper.
0023
1 MR. HOPPER: Thank Your Honor.
2 CROSS-EXAMINATION
3 BY MR. HOPPER:
4 Q Good morning, Dr. Gust.
5 A Good morning.
6 Q My name's Allen Hopper. I'm one of the
7 attorneys representing Dr. Craker in these
8 proceedings. You probably have figured that out.
9 I am just going to be asking you a few questions
10 this morning about your testimony.
11 You talked to us about the--about NIDA's
12 mission. Isn't it true that it's not NIDA's
13 mission to study the medicinal uses of marijuana or
14 advocate for the establishment of facilities to
15 support such research?
16 A Yes.
17 Q You told us that NIDA provides marijuana
18 that's grown by Dr. El Sohly at the University of
19 Mississippi to researchers as part of NIDA's Drug
20 Supply Program, right?
21 A Yes.
22 Q And you said that the University of
0024
1 Mississippi grows that marijuana through a contract
2 that it was awarded through a competitive bid
3 process; is that right?
4 A Yes.
5 Q Do you know, has any other person or
6 entity ever submitted a proposal in response to the
7 RFP for that contract?
8 A Yes.
9 Q Other entities have?
10 A Yes.
11 Q And can you tell me who those other
12 entities were?
13 A I don't know.
14 Q Can you tell me how many other entities
15 have responded?
16 A Well, as you know, those contracts have
17 been reissued several times over the last 25 or 30
18 years.
19 Q Right.
20 A Generally in three to five year cycles. I
21 can't tell you any specific name of an offeror
22 other than the University of Mississippi, or
0025
1 Research Triangle Institute off the top of my head.
2 I haven't been involved in the process that long
3 myself. I've only been involved since probably one
4 round before this current round in terms of the
5 contract procurement. And I believe for the last
6 one there was several offerors, actually more than
7 two, but I can't remember their names.
8 Q And are you aware of whether or not other
9 persons or entities have submitted proposals prior
10 to your becoming involved in this process?
11 A Yes.
12 Q Would you just give us a ballpark estimate
13 of--are we talking, you know, five, a dozen?
14 A I really don't know.
15 Q You told us also that NIDA makes available
16 for researchers other Schedule I drugs besides
17 marijuana through its Drug Supply Program?
18 A Yes.
19 Q But aren't there also alternative supplies
20 outside of NIDA's program of other Schedule I drugs
21 besides marijuana that are made available to
22 researchers?
0026
1 A Yes. For some Schedule I substances, yes.
2 Q But NIDA's the sole supplier of marijuana?
3 A Yes. And I think other, many other
4 Schedule I substances as well, NIDA's the only
5 supplier.
6 Q Can you tell me what those other
7 substances are?
8 A I can't off the top of my head, but there
9 are probably 50 to 100 different substances in
10 NIDA's Drug Supply Program in Schedule I, and I
11 think only a handful of those are available from
12 other sources.
13 Q So do you know whether cocaine, for
14 instance, is available from other sources?
15 A Yes, but that's not a Schedule I
16 substance.
17 Q Cocaine is Schedule II.
18 A Right.
19 Q Do you know whether LSD is a Schedule I
20 substance?
21 A That is a Schedule I substance.
22 Q Is that available from other sources?
0027
1 A I believe it is. I'm not positive, but I
2 believe it is.
3 Q And are you familiar with the drug MDMA,
4 also known as Ecstasy?
5 A Yes.
6 Q Is that drug available from other sources?
7 A I believe it is, but I'm not positive.
8 Q Are you familiar with the drug psilocybin?
9 A Yes.
10 Q Is that a Schedule I substance?
11 A Yes.
12 Q Is that available from other sources other
13 than--
14 A I don't know.
15 Q Are you familiar with the Schedule I drug
16 mescaline?
17 A Yes.
18 Q Do you know if that's available from other
19 sources?
20 A I don't know.
21 Q Are you familiar with the Schedule I drug
22 ibogaine?
0028
1 A Yes.
2 Q Do you know if that's available from other
3 sources?
4 A I don't know.
5 Q The PHS review process that you talked to
6 us about, that's required only for research
7 proposals requesting marijuana; is that correct?
8 A That's right.
9 Q So not any of the other Schedule I drugs?
10 A Correct.
11 Q I'm sorry. That are made available
12 through NIDA's Drug Supply Program?
13 A Yes.
14 Q Isn't it true, Dr. Gust, that companies
15 involved I pharmaceutical development with
16 privately funded research generally don't go
17 through a NIH peer review process?
18 MS. PAREDES: Objection, foundation.
19 JUDGE BITTNER: Would you rephrase the
20 question because I wasn't quite clear on what it
21 meant?
22 MR. HOPPER: Sure. Let me try that again.
0029
1 JUDGE BITTNER: Okay.
2 BY MR. HOPPER:
3 Q You testified that there is a NIH peer
4 review process that takes place for research that's
5 done with NIDA provided marijuana; is that correct?
6 A For research on medical applications, yes.
7 Q Right. And--
8 JUDGE BITTNER: In other words, for
9 applicants who are applying to NIDA to receive the
10 drug or for NIDA funding? I think that's where I
11 got a little confused.
12 MR. HOPPER: Well, I can break it down.
13 JUDGE BITTNER: Okay.
14 MR. HOPPER: Because I want to ask about
15 both.
16 BY MR. HOPPER:
17 Q So for someone who has received or wants
18 to receive NIH funding for research with marijuana,
19 you testified that they would go through an NIH
20 peer review process that is part of their receiving
21 funding.
22 A Right.
0030
1 Q And for researchers who are private
2 funded, who do not apply for NIH funding, you
3 testified that the peer review process is by the
4 Public Health Service Committee that was through
5 the procedures set up in the 1999 announcement?
6 A For applications looking at medical
7 applications, for--or if it's not looking at a
8 medical application, it can go through an ad hoc
9 review that NIDA conducts. So there are three
10 flavors of peer review. One is the NIH peer review
11 system. The second is the PHS Committee peer
12 review. And the third is an ad hoc review provided
13 through NIDA.
14 Q And my question to you then is, isn't
15 there a fourth flavor of peer review that occurs
16 that's completely outside of NIH, that occurs
17 through the FDA's procedures when a researcher is
18 privately funded and is working to do
19 pharmaceutical development?
20 A We only provide the peer review for
21 requests for materials that are provided by the
22 government. So if somebody has materials that are
0031
1 provided not by the government, NIH or NIDA, PHS
2 wouldn't get involved.
3 Q And to your knowledge, does that type of
4 peer review that's outside of NIH's involvement
5 because the researcher is not requesting NIDA
6 materials, does--
7 JUDGE BITTNER: i.e., drugs.
8 MR. HOPPER: i.e., drugs.
9 JUDGE BITTNER: Okay.
10 BY MR. HOPPER:
11 Q Doesn't that occur fairly regularly?
12 A You're asking about peer review? I have
13 no idea what a pharmaceutical company does in
14 regards to peer review. Certainly NIH--I mean a
15 pharmaceutical company has materials and drugs that
16 they want to test. So one might assume that they
17 have some kind of review process, but I don't know
18 that for a fact.
19 Q And the FDA reviews those protocols,
20 correct?
21 A That's right.
22 Q And the FDA reviews those protocols, and
0032
1 that's completely outside of the NIH peer review
2 process?
3 A Yes.
4 Q So if a researcher's not getting drugs
5 from NIDA--I'm sorry, you went through--you gave us
6 four steps--excuse me one moment.
7 [Pause.]
8 BY MR. HOPPER:
9 Q You testified that the process by which
10 NIDA distributes marijuana involves four steps.
11 No. 1, peer review for scientific merit. No. 2,
12 registration with DEA. No. 3, an IND is filed with
13 FDA. And No. 4, the researcher would then send in
14 an order form to NIDA. Is that correct?
15 A Yes.
16 Q So researchers that we were just talking
17 about a moment ago that are not trying to get their
18 drugs from NIDA, whose research protocols are
19 reviewed by the FDA, they only need registration
20 with the DEA; is that correct?
21 A Yes.
22 Q And their IND filed with FDA?
0033
1 A Yes.
2 JUDGE BITTNER: Dr. Gust, the order that
3 goes to NIDA, is that the DEA order form?
4 THE WITNESS: Yes, it is.
5 JUDGE BITTNER: DEA-222?
6 THE WITNESS: Yes.
7 BY MR. HOPPER:
8 Q So those researchers then don't really
9 need the benefits of the NIH peer review process
10 because the FDA is evaluating their research; isn't
11 that correct?
12 MS. PAREDES: Objection, foundation.
13 JUDGE BITTNER: Grounds?
14 MS. PAREDES: Foundation.
15 JUDGE BITTNER: If you know.
16 THE WITNESS: Could you ask me that
17 question again?
18 BY MR. HOPPER:
19 Q So those researchers that we were just
20 talking about, don't need the benefits of the NIH
21 peer review process because the FDA is evaluating
22 their protocols; isn't that correct?
0034
1 A No, it's not correct.
2 Q So those researchers that we just talked
3 about do need the benefits of NIH peer review?
4 A That's sort of apples and oranges I think.
5 The FDA process, as I understand it, reviews for,
6 primarily for safety uses, not necessarily for
7 scientific merit. So there would be no requirement
8 certainly for somebody, a pharmaceutical company or
9 company to submit to NIH for peer review, whether
10 it would be a benefit or not.
11 Q Sir, give me one moment, please. So
12 whether or not you would agree with my phraseology,
13 characterization of that as a benefit, those
14 researchers that we were just talking about, as a
15 routine matter, whose protocols were reviewed by
16 the FDA, don't go through the NIH peer review
17 process; is that correct?
18 A Yeah. As I said, only proposals that are
19 requesting material provided by the government
20 would need to go through the NIH--or funding--would
21 need to go through the NIH, PHS or ad hoc review
22 process.
0035
1 Q Is there any time limit on the PHS review
2 process?
3 A I don't understand your question.
4 Q I'm sorry. I'll rephrase that. Are there
5 any requirements in the announcement or elsewhere
6 that impose upon--
7 A No.
8 Q --PHS Review Committee some time limit in
9 which they must complete their review of protocol
10 that's submitted to them by a researcher who's
11 attempting to get marijuana from NIDA?
12 A No.
13 Q No time limit at all?
14 A Not to my knowledge.
15 Q Do you know generally how long that review
16 takes?
17 A I'd say three to six months.
18 Q Are you familiar with the application that
19 was filed by Chemic Labs?
20 MS. PAREDES: Objection, outside the
21 scope.
22 JUDGE BITTNER: I don't know yet.
0036
1 Overruled.
2 THE WITNESS: Yes.
3 BY MR. HOPPER:
4 Q Do you know--can you tell us why it took
5 two years for the PHS review process to be
6 completed with that application, resulting in the
7 denial of the marijuana?
8 MS. PAREDES: Objection, relevance.
9 JUDGE BITTNER: Overruled.
10 THE WITNESS: No.
11 BY MR. HOPPER:
12 Q When did you first become aware that Dr.
13 Craker had applied to the DEA to be registered as a
14 bolt manufacturer or marijuana?
15 A I can't remember exactly the dates, but it
16 was sometime, I believe, in 2003.
17 Q Do you know that Dr. Craker actually filed
18 his application in 2001?
19 A That's probably correct.
20 Q Can you just briefly outline for us the
21 full extent of your involvement relating to his
22 application prior to your testimony today?
0037
1 A I had no direct involvement in his
2 application. Is that what you're asking me, what
3 involvement I had in his application to DEA?
4 Q What was your involvement with his
5 application, the response to his application?
6 A The response to his application?
7 JUDGE BITTNER: From whom?
8 BY MR. HOPPER:
9 Q From--I guess what I would like to know is
10 what did you do that was in relationship to Dr.
11 Craker's application that was filed with the DEA
12 for registration?
13 A Oh, I commented on Dr. El Sohly's
14 response to the application.
15 Q You also testified, I think, that you had
16 some discussions with DEA about Dr. Craker's
17 application?
18 A Yeah. I think I was notified that he had
19 filed something with DEA about this.
20 Q Do you remember who notified you?
21 A No. I think it may have--Mr. Sapienza
22 (ph), I think, at the time.
0038
1 Q Do you remember whether that notification
2 was by way of a phone call?
3 A It was a phone call.
4 Q Did you receive anything from writing, in
5 writing from the DEA about the application?
6 A Not that I recall.
7 Q Do you remember if there were more than
8 one phone conversations with DEA about the
9 application?
10 A There may have been more than one, but
11 not--you know, one or two.
12 Q Do you recall a meeting in January of 2004
13 with, among others, representatives from DEA about
14 Dr. Craker's application?
15 A Yes.
16 Q Can you tell us about that meeting?
17 A Well, I have very, very--I'm sorry, but I
18 have very little recollection of that meeting other
19 than it occurred. Do you have something that could
20 prompt my memory?
21 Q Can you tell us who else was there?
22 A No, I can't.
0039
1 Q So if I suggested to you that Helen
2 Kaupang from DEA was there, would that refresh your
3 memory?
4 A No.
5 Q Matt Strait from DEA?
6 A I may remember him being there.
7 Q Tim Condon?
8 A Yes.
9 Q So does that help you remember anything
10 more about--
11 A About the substance of the meeting?
12 Q Just generally?
13 A Yeah, just--quite honestly, I think it was
14 just basically providing us some information on the
15 status of the application that had occurred and the
16 status at that time, information. It was
17 informational.
18 Q Have you ever before been called to a
19 meeting to discuss the application filed by some
20 person to become a bulk manufacturer of a
21 controlled substance?
22 A No, not to my recollection.
0040
1 Q So would you characterize that as an
2 unusual meeting?
3 A Perhaps, but generally we have meetings
4 with DEA on a variety of topics. We share
5 information on topics of mutual interest
6 frequently, and so this was just another one of
7 those topics. So it wasn't extraordinary in that
8 respect.
9 Q I'm sorry. But it was specific to--this
10 meeting was specific to Dr. Craker's application?
11 A You know, I don't even recall that now
12 that you bring it up. There may have been several
13 other items on the agenda. I'd have to go back and
14 see if I even had notes from then. It's very
15 possible and likely actually that there were other
16 issues on the agenda.
17 Q And then at some point you became aware
18 then, probably before this meeting, that Dr.
19 Craker's application and notice of Dr. Craker's
20 application had been published in the Federal
21 Register?
22 A Yes.
0041
1 Q And you became aware that Dr. El Sohly was
2 sending in comments to the Federal Register?
3 A Yes.
4 Q Did you discuss with anyone at DEA whether
5 or not Dr. El Sohly would submit comments
6 responding to Dr. Craker's application?
7 A I don't recall that at all.
8 Q Are you familiar with the requirements
9 under the Statute 21 USC 823 as they pertain to Dr.
10 Craker's application to be registered as a
11 manufacturer?
12 A No, I'm not familiar.
13 Q So prior to reviewing Dr. Craker's
14 application, you didn't have any sort of expertise
15 in the application of that criteria to an
16 application to be registered as a manufacturer?
17 MS. PAREDES: Objection, assumes facts not
18 in evidence. This witness never testified that he
19 reviewed Dr. Craker's application.
20 JUDGE BITTNER: Sustained.
21 BY MR. HOPPER:
22 Q Did NIDA officially oppose Dr. Craker's
0042
1 application?
2 A No.
3 Q Were you opposed to Dr. Craker's
4 application?
5 A Not at all.
6 Q So did you consider sending a response
7 yourself to the Federal Register from NIDA or from
8 yourself, independent of Dr. El Sohly's letter?
9 A As I recall, it was discussed within NIDA
10 and it was decided that there would be no response
11 from NIDA?
12 Q And you've said that NIDA didn't oppose
13 and you didn't oppose the application. But would
14 you characterize Dr. El Sohly's comments as being
15 in opposition to the application, in opposition to
16 the granting of the application I should say?
17 A Yes.
18 Q I'm sorry?
19 A Yes.
20 Q I'm just trying to understand. If NIDA's
21 not opposed, you're not opposed. Dr. El Sohly
22 clearly is, and you're assisting him with his
0043
1 opposition, did you--
2 A I wouldn't say I was assisting him. As I
3 recall the series of events, he approached NIDA
4 with his intent to respond, and NIDA said, "Fine."
5 And he did share copies of drafts of his response
6 with NIDA, and I do recall looking at those, but
7 for factual--primarily at least for factual
8 accuracy. And so he did solicit a review for that
9 reason, and we provided it.
10 JUDGE BITTNER: When you say NIDA, who in
11 NIDA would make these decisions?
12 THE WITNESS: About--in terms of reviewing
13 the staff response?
14 JUDGE BITTNER: In terms of reviewing Dr.
15 El Sohly's response, and also in terms of deciding
16 whether or not NIDA would file comments. Who
17 actually makes those decisions?
18 THE WITNESS: Either the director or the
19 deputy director, penultimately made that decision.
20 BY MR. HOPPER:
21 Q Thank you. The process that you've just
22 described of Dr. El Sohly asking for input or
0044
1 assistance,and I'll turn to that in a moment. But
2 was this the first time that you have engaged in
3 that sort of a process with someone responding to
4 an application to be permitted to become a bulk
5 manufacturer?
6 A Yes.
7 Q And are you aware of any prior occasion in
8 which NIDA has played that sort of a role in
9 working with someone opposing an application to
10 manufacture?
11 A There have certainly been other occasions
12 when a NIDA contractor has responded to--has
13 responded in various circumstances, where the
14 contractor would certainly have--you know, work
15 with NIDA staff, whether it's working with them or
16 having products reviewed prior to their submission,
17 not in this specific case, but there are other
18 instances, yes.
19 MR. HOPPER: Can Dr. Gust please be
20 provided with a copy of Respondent's Exhibit 5?
21 [Pause.]
22 BY MR. HOPPER:
0045
1 Q Do you have that, Dr. Gust?
2 A Yes.
3 Q Can you just please take a look at that
4 document and tell me if you recognize it?
5 A Yes.
6 Q Is this a printed version of an e-mail
7 that you received from Dr. El Sohly on August 29,
8 2003 with his draft comments on the DEA published
9 version of Dr. Craker's application?
10 A Yes.
11 Q And that has attached to it the draft
12 comments from Dr. El Sohly?
13 A Yes.
14 Q Did you discuss the application with Dr.
15 El Sohly prior to receiving this e-mail, do you
16 know?
17 A I believe he informed me of his intent to
18 respond.
19 Q Do you recall if it was your suggestion or
20 Dr. El Sohly's suggestion that he send you a draft
21 so that you could review it?
22 A It was his suggestion, as I recall.
0046
1 Q Looking at that e-mail, he wanting your
2 view in particular, do you see the sentence where
3 he's referring to being aware that there might be
4 information that NIDA wouldn't want him to share?
5 It's in that second paragraph.
6 A Yes, I see that.
7 Q "I understand, Dr. Gust and Dr. Singh,
8 that I might have information there that NIDA would
9 not want me to include, and I'll certainly remove
10 it if that's the case." You see that?
11 A Yes.
12 Q Do you have any ideas about what
13 information he might be referring to there that
14 NIDA would be concerned about, from your
15 conversations with him?
16 A No.
17 Q Can you tell us what was your general
18 reaction to Dr. El Sohly's first draft there?
19 A I thought there were a few factual errors
20 that needed to be corrected. In general though, I
21 didn't have any problem with it.
22 MR. HOPPER: Can we, please, now provide
0047
1 Dr. Gust with a copy of Respondent's Exhibit 6?
2 [Pause.]
3 BY MR. HOPPER:
4 Q Do you have that, Dr. Gust?
5 A Yes.
6 Q Can you please take a look at that
7 document and tell me if you recognize it?
8 A Yes.
9 Q Do you recall receiving the second draft
10 of Dr. El Sohly's comment regarding Dr. Craker's
11 application?
12 A Yes.
13 Q And does this appear to be a printed
14 version of the e-mail that he sent you in that
15 regard?
16 A Yes.
17 Q And the draft that's attached there. It
18 says Draft No. 2?
19 A Yes.
20 Q And you made corrections to that draft, is
21 that right?
22 A I may have.
0048
1 Q Do you recall making corrections to a
2 draft that he had sent you and then e-mailing them
3 back to him?
4 A I remember making some comments in an e-mail. I
5 don't actually recall making changes to
6 the letter itself.
7 MR. HOPPER: Sorry to make you keep
8 getting up, Nicole. Can you please provide Dr.
9 Gust with a copy of Respondent's Exhibit 7?
10 [Pause.]
11 BY MR. HOPPER:
12 Q Do you have that, Dr. Gust?
13 A Yes.
14 Q Can you please take a look at that
15 document and tell me if you recognize it.
16 A Yes.
17 Q So does this appear to be a printed
18 version of the e-mail from you back to Dr. El
19 Sohly?
20 A Yes.
21 Q And you see attached to it there is that
22 draft. It says Draft No. 2 still?
0049
1 A Yes.
2 Q And you see down beginning in that last
3 paragraph on that first page, there are some
4 strikeouts and additions of text underlined?
5 A Right.
6 Q Did you make those edits?
7 A This is the part I remember changing,
8 because, yes, the language that he had originally
9 was incorrect, so I made some changes to make it
10 consistent with the policies at the time in that
11 paragraph, and then in the next page, the same
12 changes.
13 Q Excuse me. I'll go through some of these
14 with you. I just want to first though have you
15 look, just glance at the second and third page, and
16 you should see that there's strikeout text and then
17 text that's been underlined. So is it your
18 recollection now that those reflect your changes or
19 your suggested changes to Dr. El Sohly's draft?
20 A Yeah, just let me read them, and then I'll
21 get back to you.
22 Q Sure.
0050
1 [Pause.]
2 BY MR. HOPPER:
3 Q And just so there's no confusion, Dr.
4 Gust, on that third page there are some handwritten
5 comments. At this point I'm just asking about the
6 stuff that's been--it looks like using a word
7 processing program probably. Text has been
8 stricken and other text added with underlines, and
9 I just want to know if you made those changes, and
10 those are the changes that are referred to in your
11 e-mail back to Dr. El Sohly when you say that, "I
12 have made a few suggested changes. Please take a
13 look."
14 A I don't recall--I recall making the
15 substantive changes in that last paragraph on the
16 first page, and the continuation of the strikeouts
17 and the underlining in that paragraph.
18 The second page, the bottom of page 2, I
19 don't recall making that suggestion strikeout
20 actually. I did suggest that he put a comment in
21 here about the complaints, so that sentence,
22 something I would have suggested. The next
0051
1 paragraph which is stricken, I have no recollection
2 of making that suggestion to him.
3 Q I'm sorry. The one you're referring to
4 now that you're saying you have no recollection
5 making that--
6 A In addition to--the one that starts, "In
7 addition to the above described NIDA program."
8 Q Right.
9 A So I guess what I don't know is if this--I
10 don't think this is the actual marked up draft of
11 my changes. It looks like somebody may have
12 combined some changes from several people, or some
13 recommendations, and put them in this draft.
14 Q Well, let's just go through these one at a
15 time then and see which ones you recall having made
16 and what you can tell us about them.
17 A Okay.
18 Q On the first page, that last paragraph on
19 the page, second line, "Registration with the DEA,"
20 and then it looks like new text "and FDA" has been
21 added. Was that a change that you suggested?
22 A Yes, or I would have, yes.
0052
1 Q And can you tell us why you would have
2 added the FDA?
3 A Well, as previously described, there's
4 really three things that need to happen before NIDA
5 can make marijuana available. That include the DEA
6 registration and the FDA IND application, and peer
7 review. So Dr. El Sohly's draft letter did not
8 include the requirement for the FDA, so that was
9 added.
10 Q Okay. And then the next sentence looks
11 like the sentence has been stricken, "Those
12 researchers are required to provide proposals and
13 protocols for their studies to NIDA for review."
14 Do you know why you would have suggested to strike
15 that sentence?
16 A Because the proposals and protocols are
17 sometimes provided to NIDA, but sometimes not.
18 Sometimes they're provided--it would be to the PHS
19 Committee by this time.
20 Q Okay. In that next sentence, "Those
21 researchers with projects approved," and then "and
22 funded" has been added, and then by--and then it's
0053
1 been added, "NIH including NIDA, receive marijuana
2 at no cost to them and their institutions." You
3 suggested those changes?
4 A Yes.
5 Q And the reason being?
6 A To make it more accurate. I guess the
7 previous--previously it must have read, "Those
8 researchers with projects approved by NIDA receive
9 marijuana at no cost to them or their
10 institutions." That was just not correct.
11 Q Right. This again is reflecting what you
12 told us earlier about sort of the two categories of
13 research projects that might be seeking marijuana
14 from NIDA, one being NIH funded and the others
15 being privately funded.
16 A Right.
17 Q And then it looks like the following
18 sentence, "Those researchers with projects," and
19 then "do not meet," well, that sentence has been
20 changed. It looks like it used to read: "Those
21 researchers with projects"--yeah, did you make that
22 change? I guess I'm not going to try to struggle
0054
1 to figure out what it said before.
2 A Yes.
3 Q Can you tell us what you were seeking to
4 correct or change with that language?
5 A That simply is stating that--as you just
6 stated--there are two types--for the researchers
7 that weren't requesting NIH funding but got
8 approved, then they would receive marijuana, but
9 they would have to pay for it.
10 Q So that paragraph now as it reads with
11 your suggested changes, it doesn't say so, but by
12 scientific approval there in that sentence we were
13 just talking about, that was added?
14 A Uh-huh.
15 Q By "scientific approval" you were
16 specifically referring to PHS review, right, and
17 not the FDA or DEA review that is referred to in
18 that first sentence?
19 A Either PHS review approval or ad hoc
20 consultant review if it was not a medical marijuana
21 project.
22 Q Right, okay. So although it's not really
0055
1 acknowledged clearly in that paragraph as changed,
2 there could be FDA and DEA approved studies that
3 would not necessarily receive marijuana even if
4 they were willing to pay for it, because they
5 didn't get PHS review, right?
6 A That's right.
7 Q And then turning to the second page, there
8 is, again, "NIH or NIDA" is added there. That's
9 your correction?
10 A Yes.
11 Q And I think we understand that from what
12 you've told us before, that there could be NIH
13 approval through the peer review process that
14 happens when someone applies for funding.
15 A Right.
16 Q And then you--the next stricken text is
17 "not approved by NIDA," and that's been replaced
18 with "funded by other sources?"
19 A Yes.
20 Q That's your change?
21 A Yes.
22 Q So doesn't that, with your change, kind of
0056
1 suggest that all research that was--been approved
2 by the government and funded by other sources,
3 would be provided with marijuana from NIDA?
4 A What's approved by the government?
5 Q Yeah. I'm just trying to--right. It
6 says, "These cigarettes are provided to researchers
7 at no charge if their project is approved by NIH or
8 NIDA, or at cost if the project is," and then
9 "approved" is taken out and it just says, "funded
10 by other sources." But isn't it true that there
11 could be projects funded by other sources that
12 aren't going to be supplied with marijuana?
13 A Yeah. I would say the availability of
14 funding for the project was not a requirement for
15 obtaining or receiving peer review. The thing here
16 is that any government provided resource--in this
17 case, marijuana, needed to have a review for
18 scientific merit, and maybe that's part of the
19 issue here, is that any--the issue here is that for
20 government funded research or for government
21 provided resources, there needed to be a judgment
22 whether or not the project was scientifically
0057
1 meritorious, and absent that, government resources
2 could not be use, or the government marijuana could
3 not be provided.
4 Q All right. But just to be clear though,
5 this sentence again is suggesting--it says that,
6 "These cigarettes are provided to researchers at no
7 charge if the project's approved or at cost." So
8 it's suggesting that if someone is funded by other
9 sources and it's not a project that's been approved
10 by NIDA or NIH, that they would be provided
11 marijuana at cost, when in fact, some of those
12 people aren't going to get marijuana at all; isn't
13 that true?
14 A Yes. Yes, if they don't have the
15 scientific review, they're not approved.
16 Q So now just moving to the bottom of that
17 page, is this one of the changes that you said you
18 don't think was your own?
19 A I don't recall making that suggestion. I
20 would have no comment on the factual accuracy of
21 that, so I would have--I wouldn't have a comment on
22 that.
0058
1 Q Okay. And the last sentence in that
2 paragraph, you said that it is a sentence that you
3 could imagine?
4 A Yes.
5 Q Did you recall suggesting that that--
6 A I do recall suggesting that he add a
7 sentence I here about the actual experience that he
8 had in terms of receiving complaints about the
9 marijuana quality.
10 JUDGE BITTNER: So we're looking at the
11 added sentence in the first paragraph on page 2?
12 THE WITNESS: Right.
13 JUDGE BITTNER: I just want to--it occurs
14 to me we've kind of been talking about this. Are
15 we all agreed that in these drafts the words that
16 are struck through are deleted using some kind of
17 revision tool, and the underlining is material
18 that's added? Are you all willing to stipulate to
19 that?
20 MR. HOPPER: That's been my understanding,
21 and I thought I had gotten Dr. Gust's agreement
22 that that looked like what had happened.
0059
1 JUDGE BITTNER: But we don't have a
2 stipulation that that is indeed what happened, as
3 opposed to somebody just merrily running around
4 striking through things and underlining things.
5 MR. HOPPER: That's true, Your Honor,
6 although we do have the final submitted version
7 which tracks that understanding of what the--
8 JUDGE BITTNER: Ms. Paredes, are you
9 willing to stipulate that in these drafts what was
10 stricken through was intended to show proposed
11 deletions, and what was underlined was intended to
12 show proposed insertions?
13 MS. PAREDES: Yes, Your Honor, and I
14 believe that's consistent with Dr.Gust's testimony.
15 JUDGE BITTNER: Okay, thank you.
16 MR. HOPPER: Right, and with Dr. El
17 Sohly's testimony.
18 JUDGE BITTNER: It just occurred to me
19 that we should get that nailed down.
20 MR. HOPPER: Thank you. One moment.
21 BY MR. HOPPER:
22 Q Turning then to that next paragraph that's
0060
1 completely stricken.
2 JUDGE BITTNER: On page 3?
3 BY MR. HOPPER:
4 Q On page 3. It begins, "In addition to the
5 above-described NIDA program." Do you see that
6 paragraph, Dr. Gust?
7 A Yes.
8 Q I believe you said that that's not a
9 change that you recommended.
10 A I don't recall making any suggestion on
11 that wording.
12 Q Have you read that paragraph?
13 A Yes.
14 Q Do you--is it factually accurate?
15 A I don't know.
16 Q So what the paragraph is suggesting--I'll
17 paraphrase and please tell me if you disagree. Is
18 that Dr. El Sohly, with a registration, a DEA
19 registration outside of his NIDA contact, is
20 cultivating marijuana legally, and that he could
21 provide some of that marijuana to researchers
22 outside of NIDA's program outside of the NIDA peer
0061
1 review process. Would you agree that that's a
2 correct reading of that paragraph?
3 MS. PAREDES: Objection.
4 JUDGE BITTNER: Grounds?
5 MS. PAREDES: Asked and answered.
6 MR. HOPPER: I'm sorry. I didn't hear the
7 objection.
8 JUDGE BITTNER: Asked and answered. The
9 witness said he didn't know if it was accurate or
10 not.
11 MR. HOPPER: I'm not asking about--I'm
12 sorry. He read the paragraph and said he didn't
13 know if the paragraph itself was accurate, and I'm
14 trying to elicit from Dr. Gust what he believes
15 that paragraph says, what it describes.
16 JUDGE BITTNER: Okay. Why don't you ask
17 him that?
18 BY MR. HOPPER:
19 Q So isn't it true that what this paragraph
20 describes is that Dr. El Sohly, growing marijuana
21 with his license, registration to do so that's
22 separate from his NIDA contract, could provide some
0062
1 of that marijuana to medical marijuana researchers
2 outside of the NIDA program without NIDA peer
3 review?
4 MS. PAREDES: Objection, calls for
5 speculation, and the document speaks for itself.
6 JUDGE BITTNER: Overruled.
7 THE WITNESS: I can only reiterate what--well, I
8 think you just basically paraphrased this
9 sentence, "Materials could be made available to
10 researchers outside the NIDA program if they are
11 properly registered with the DEA, and for some
12 reason do not wish to receive or are not qualified
13 to receive materials under the NIDA program." I
14 have no way of knowing if that's true or not.
15 JUDGE BITTNER: Do you interpret that
16 sentence to say just what it says, I guess?
17 THE WITNESS: Yeah. I mean--
18 JUDGE BITTNER: Well, every once in a
19 while, what is said and what is meant aren't
20 necessarily the same, and only people knowledgeable
21 in the field would know that.
22 THE WITNESS: Oh, yes.
0063
1 BY MR. HOPPER:
2 Q Are you aware, Dr. Gust, that Dr. El Sohly
3 has a DEA registration that permits him to
4 cultivate marijuana at the University of
5 Mississippi outside of the parameters of the NIDA
6 contract?
7 A Yes.
8 Q And is it your testimony that you do not
9 know whether that marijuana could be provided,
10 legally provided by Dr. El Sohly to medical
11 marijuana researchers?
12 A That is my testimony.
13 Q Just--I know that you've said that you
14 didn't--you don't recall having made these changes.
15 Would it surprise you or refresh your recollection
16 if I told you that Dr. El Sohly testified that in
17 his recollection it was you who explained to him
18 that in fact what that paragraph states is not
19 true, is not accurate, and would not be provided,
20 or would not be legal?
21 A I would have a very different recollection
22 of that, because I definitely would not feel
0064
1 qualified to comment on whether or not that was
2 true or possible or feasible.
3 Q Okay, thank you. So just one last
4 question then on this subject. So NIDA doesn't--you said,
5 you testified that you are aware that Dr.
6 El Sohly has a separate DEA registration that
7 permits him to cultivate marijuana at the
8 University of Mississippi outside the parameters of
9 the NIDA contract; is that correct?
10 A Yes.
11 Q And it's your testimony them that NIDA
12 does not supervise or control in any way Dr. El
13 Sohly's activities in that regard?
14 A Correct.
15 Q You don't--NIDA doesn't supervise them,
16 oversee them, license them?
17 A No.
18 Q Are you aware that Dr. El Sohly has in the
19 past conducted non-clinical analytical research
20 with the marijuana he grows under that second
21 registration?
22 A I'm sorry. Could you ask that again? I'm
0065
1 sorry.
2 Q Sure. Are you aware that Dr. El Sohly has
3 in the past conducted nonclinical, analytical
4 research using the marijuana that he grows outside
5 of his NIDA contract?
6 A I have no knowledge of what he does with
7 the marijuana he grows on that separate contract.
8 Q So I'm assuming then that that--well,
9 maybe I shouldn't assume. I should back up. Would
10 it be your testimony then that any of that research
11 that he's doing is not subject to NIDA supervision?
12 A If he were doing some of it under an NIH
13 grant or with NIH funding, he would, but absent
14 that, no.
15 Q So absent NIH grant or funding, that
16 research wouldn't be subject to NIDA supervision,
17 wouldn't be subjected to the PHS review that we've
18 been talking about; is that correct?
19 A Correct.
20 Q Are you aware of any other authorized
21 privately funded research with marijuana that is
22 able to avoid that PHS review process other than
0066
1 Dr. El Sohly's own research?
2 A Yes. You mean on medical marijuana?
3 Again, we always have the preclinical work that--there is
4 some of that going on.
5 Q I'm sorry. Just to clarify, the
6 preclinical work that you're referring to is
7 reviewed by this other ad hoc process that we
8 referred to, so it's not the PHS review process; is
9 that correct?
10 A Right, right.
11 Q So, yeah, excluding that.
12 A So ask me your question again. Sorry.
13 Q Sure. Are you aware of other authorized,
14 privately funded research with marijuana that is
15 not subject to either the PHS review or this other
16 ad hoc NIH review that you've talked to us about?
17 A No, not in the U.S.
18 MR. HOPPER: Can Dr. Gust please be
19 provided with a copy of Government's Exhibit 24?
20 [Pause.]
21 JUDGE BITTNER: Could I just ask, Mr.
22 Hopper, when you refer to privately funded, do you
0067
1 mean not federally government funded? I'm just
2 thinking--
3 MR. HOPPER: I apologize, Your Honor. I
4 understand your confusion. When I refer to
5 privately funded--and I should have made this
6 clear--I'm using that as a shorthand for non-Federal
7 Government funded, non-NIH, I should say,
8 funded research.
9 JUDGE BITTNER: And that's what you meant
10 too, doctor?
11 THE WITNESS: Yes.
12 JUDGE BITTNER: I just want to be sure you
13 were both in the same page here. Could there be,
14 for example, research that is funded by some other
15 agency of the Federal Government other than NIH or
16 HHS, that, say, goes through an academic
17 institution or also research that's funded by a
18 state government, right?
19 THE WITNESS: Uh-huh.
20 JUDGE BITTNER: So what we're really
21 talking about, when you say "private" you mean non-NIH.
22 THE WITNESS: Right.
0068
1 JUDGE BITTNER: Okay.
2 MR. HOPPER: Right. For instance, there
3 was the CMCR research that was--
4 JUDGE BITTNER: State funded.
5 MR. HOPPER: State funded, but not NIH
6 funded.
7 THE WITNESS: Correct.
8 MR. HOPPER: Thank Your Honor. I should
9 have been more clear with that.
10 BY MR. HOPPER:
11 Q Do you have Government's Exhibit 24 in
12 front of you, Dr. Gust?
13 A Yes.
14 Q And do you recognize that document?
15 A Yes.
16 Q So that's the one that you were talking
17 about in your direct testimony as setting out the
18 guidelines for PHS review for marijuana research?
19 A Right.
20 Q So for the record, I'm just going to refer
21 to this document during these questions as the 1999
0069
1 NIH announcement.
2 Dr. Gust, do you know, are there
3 additional regulations or guidelines beyond this
4 1999 NIH announcement that governed the provision
5 of marijuana to privately funded, as we now
6 understand that term to be defined, privately
7 funded researchers?
8 A Just the FDA's IND process and the DEA
9 registration process.
10 Q And the ad hoc review process that you've
11 talked to us about, are there separate guidelines
12 or criteria for that process that exist somewhere?
13 A They're generally the same as the NIH peer
14 review criteria that we talked about earlier in
15 terms of looking at the scientific significance and
16 the approach and the--you know, the quality of the
17 investigators and the environment, they're the
18 same.
19 Q So it's they mirror or are closely related
20 to the guidelines that NIH uses when determining
21 whether or not to approve a research grant?
22 A Yes.
0070
1 Q And the guidelines in this 1999 NIH
2 announcement set out the criteria that's used by
3 the PHS review committee that you referred to in
4 your direct testimony, to determine whether or not
5 NIDA will marijuana to a privately funded
6 researcher, isn't that right?
7 A Yes.
8 Q And just to clarify another point of
9 terminology here, we've been referring to PHS
10 review and a PHS Committee. Can you just
11 distinguish for me what--I know that PHS refers to
12 Public Health Service, which I assume has a great
13 many other responsibilities than just reviewing
14 research protocols for marijuana, is that right?
15 A Yes.
16 Q So the PHS review that's being referred
17 to, that is review that is conducted by a committee
18 of the Public Health Service, is that correct?
19 A Yes. Members are from the Public Health
20 Service and its components, NIH, FDA.
21 JUDGE BITTNER: You just lost me. The
22 Public Health Service--so the people who do the
0071
1 peer review, the PHS review, are they employees of
2 the Public Health Service?
3 THE WITNESS: Inasmuch as I'm an employee
4 of the Public Health Service. In other words, the
5 Public Health Service runs the committee, chairs
6 the committee and runs the committee. The members
7 of the committee are from the PHS and its component
8 agencies including FDA, NIH--
9 JUDGE BITTNER: The PHS--oh, I'm really
10 confused. So PHS is the umbrella within the
11 Department of Health and Human Services?
12 THE WITNESS: Yes.
13 JUDGE BITTNER: For NIH, FDA?
14 THE WITNESS: Yes.
15 JUDGE BITTNER: Oh, okay. Maybe I need an
16 organizational chart of HHS.
17 MR. HOPPER: Yeah, I could also benefit
18 from--
19 MR. BAYLY: Excuse me. I just want to
20 note for the record, we do have an exhibit that's
21 going to cover it. It's a statute that I think
22 just lists the agencies.
0072
1 JUDGE BITTNER: Okay, because I didn't
2 realize that. That's why I was so confused.
3 MR. HOPPER: I'm sorry. Ms. Paredes, has
4 that exhibit already been introduced? Is there a
5 way to--
6 MS. PAREDES: It's not been introduce yet,
7 but it's Government Exhibit--
8 MR. BAYLY: No, it hasn't been introduced
9 yet.
10 JUDGE BITTNER: But could we refer to it?
11 That might help.
12 MR. HOPPER: --that I could refer to as
13 we're--
14 MR. BAYLY: Yes.
15 MR. HOPPER: What's the number that was
16 assigned?
17 MR. BAYLY: I knew you were going to ask
18 that.
19 [Laughter.]
20 JUDGE BITTNER: No pointing, Mr. Hopper.
21 MR. HOPPER: Excuse me. I was scratching
22 you head.
0073
1 JUDGE BITTNER: Yeah, yeah, that's what
2 they all say.
3 MR. HOPPER: Perhaps 34, Government's
4 Exhibit 34?
5 JUDGE BITTNER: Yes, that's what it looks
6 like.
7 MR. BAYLY: Yes.
8 JUDGE BITTNER: My word.
9 MR. HOPPER: Thank you very much, Mr.
10 Bayly.
11 MR. BAYLY: Can we move to admit this
12 right now then?
13 JUDGE BITTNER: Any objection, Mr. Hopper?
14 MR. HOPPER: No objection.
15 JUDGE BITTNER: Government 34 is received.
16 [Government's Exhibit No. 34
17 received in evidence.]
18 BY MR. HOPPER:
19 Q So, Dr. Gust, who set up the PHS
20 Committee? Is that the PHS that established the
21 committee, or was it NIH?
22 A PHS.
0074
1 Q And can you just tell me the organizations
2 from which its members, the PHS Review Committee's
3 members are drawn?
4 A FDA, NIH, primarily. I believe other
5 agencies are--have been--I'm trying to remember if
6 they actually were members--but SAMSA, the
7 Substance Abuse and Mental Health Services
8 Administration. I think those three.
9 Q Thank you. So the guidelines that we're
10 looking at Government's Exhibit 24, they--isn't it
11 true that they establish a level of review that is
12 above and beyond FDA approval and DEA approval of
13 the research protocol?
14 A I would say--above and beyond--I would say
15 no, because there's always been a requirement for
16 scientific review, whether it's provided through
17 the NIH peer review system or the NIDA ad hoc
18 system prior to 1999. So this was just adding one
19 more way of achieving that scientific peer review.
20 It's not above and beyond. It's just an
21 alternative method to achieve that.
22 Q But for researchers who have not applied
0075
1 for NIH funding, don't these guidelines set out
2 criteria and a review process that is an additional
3 layer of review beyond just the DEA registration
4 and FDA review of protocol that would be--
5 A Not for anybody looking for government
6 resources, i.e., government provided marijuana.
7 Q Right. That's my--
8 A If it's not government provided marijuana,
9 then it would be, but those are reviewed, as you
10 previously stated. Those go to the FDA and the DEA
11 for other Schedule I drugs, for example, that are
12 available from other sources. So any applicant
13 looking for government resources, i.e., government
14 provided marijuana, has always needed to be
15 subjected to a scientific peer review to determine
16 whether or not it was scientifically meritorious.
17 Q Right. But someone who, a researcher who
18 is not seeking government provided resources, who
19 wants to do research with a controlled substance
20 other than marijuana, would not need to go through
21 this type of a review process, right?
22 A Correct.
0076
1 Q So just to be clear, a privately funded
2 researcher might well obtain the appropriate DEA
3 Schedule I registration, have their protocol
4 reviewed and approved by the FDA, and still be
5 denied access to NIDA marijuana by a PHS Committee
6 under the conditions and priorities that are set
7 forth in this document; isn't that correct?
8 A Yes.
9 Q And PHS, for instance, gives preference to
10 protocols that have specific safety or efficacy
11 endpoints. Is that one of the criteria that they
12 establish here?
13 A That's in the guidance, yes.
14 Q And therefore, protocols for ongoing
15 trials are not likely to be deemed eligible to
16 receive NIDA marijuana, isn't that correct?
17 A Not necessarily. I'm a little confused by
18 the question. How could it be an ongoing trial if
19 they didn't have marijuana, if they're going to use
20 marijuana?
21 Q Sorry. Just give me a moment. I want to
22 refer to a specific part of this document. So
0077
1 turning your attention then to the third page of
2 that document, Dr. Gust, see that heading, Roman
3 numeral IV, Marijuana Trial Design Elements?
4 A Yeah.
5 Q Second paragraph, second sentence.
6 "Protocols for open-ended or ongoing trials that do
7 not include ending dates are not likely to be
8 eligible to receive marijuana."
9 A You're asking what that means?
10 Q Yes. Can you give me an example that
11 illustrates the difference between a specific
12 endpoint and an ongoing trial?
13 A Well, I didn't draft this, but let me see
14 if I can help. I think it's just simply stating
15 that preference would be given to controlled
16 studies that had specific start and endpoints, and
17 in terms of both time and the outcome measures.
18 The next sentence that you read I think is
19 referring to basically what it says. Open-ended
20 trials are trials that have no specific endpoints
21 in terms of time or outcome measures. So basically
22 it just goes back to kind of the scientific rigor
0078
1 and merit of the application, and it's simply
2 stating that priority would be given to those that
3 had more clear-cut goals and endpoints than those
4 who did not.
5 Q Okay. Thank you, Dr. Gust. I'm trying to
6 understand that distinction. I mean are you able
7 to provide an example of a--can you sort of
8 describe for us a hypothetical study that would be
9 uneligible under that criteria?
10 A I cannot.
11 JUDGE BITTNER: Do most studies have
12 endpoints?
13 THE WITNESS: Most do.
14 JUDGE BITTNER: You say we're going to do
15 this for three months or two years or 40 years or
16 whatever.
17 THE WITNESS: Yeah, absolutely.
18 BY MR. HOPPER:
19 Q Isn't it true that this 1999 NIH
20 announcement evinces a strong PHS preference for
21 clinical research?
22 A It's all about clinical research, isn't
0079
1 it?
2 Q I'm sorry. When you say it's all about,
3 are you referring to--
4 A This whole guidance is about clinical
5 research, that is, studies of the medical
6 applications of marijuana in patients, would all be
7 clinical studies.
8 Q Right. But a study, for instance, that
9 wanted to measure the functionality of a vaporizer
10 device to measure the output of that device when
11 marijuana is vaporized on it, with the intention of
12 eventually being able to use that kind of device in
13 a clinical trial.
14 A Right.
15 Q Would be hard pressed to qualify under
16 these criteria and guidelines; is that true?
17 A Not at all.
18 JUDGE BITTNER: No, it wouldn't be hard
19 pressed to qualify?
20 THE WITNESS: Would not be hard pressed.
21 BY MR. HOPPER:
22 Q I'm just trying to understand why you say
0080
1 that in light of your previous comment that really
2 this is all about clinical research?
3 A Well, studies of--vaporizer studies, as
4 you described them, would be clinical studies.
5 Looking at--certainly, you know, the delivery of
6 marijuana constituents in a vaporizer to be
7 delivered to human patients would be a clinical
8 study.
9 Q I understand that. I was asking about a
10 study that, a research protocol that proposed to do
11 a study preliminary to clinical studies.
12 A Right.
13 Q That would just be an analytical--
14 A There would be no prejudice against those
15 types of studies based on this guidance, nor has
16 there been in practice.
17 Q Isn't it true that the PHS Review
18 Committee will examine the goals of a proposed
19 research protocol to see if those goals are
20 consistent with those described in this
21 announcement?
22 A In practice the Committee has reviewed
0081
1 projects primarily based on--not primarily--exclusively
2 based on the review criteria, as I
3 previously described.
4 Maybe this would be a good point to just
5 say a little bit more about the review process at
6 NIH and the review process at--in terms of what
7 they do, in terms of making judgments about the
8 scientific merit of a proposal. The NIH committees
9 typically make--first they make an initial cut
10 about whether a project is not recommended for
11 further consideration, i.e., disapproved. That's a
12 certain percentage of the proposals that get not
13 recommended for further consideration and they're
14 disapproved.
15 All the other proposals get reviewed, and
16 basically they get a score, they get a grade. They
17 get a grade from 1 to 5, where 1 is the best and 5
18 is the worst, but 1 through 5 are all approved.
19 And there's basically a priority score, it's
20 called, in terms of Number 1 is the highest
21 priority, Number 5 is the lowest priority. And
22 then all the approved projects can be considered
0082
1 for funding by whatever NIH institute a proposal is
2 assigned to.
3 In practice, of course, there's never
4 enough money to fund all the approved projects, and
5 so what happens is generally projects with
6 priorities between 1 and 2, there's a cutoff
7 between 1 and 2, so only the highest-ranked
8 projects get funded. The PHS Committee uses sort
9 of a similar kind of metric, where there's--projects can be
10 not recommended for further
11 consideration or disapproved, or they can be ranked
12 high priority, low priority, but basically it's a
13 decision of whether it's approved or not approved,
14 and the PHS Committee in practice has basically not
15 discriminated against--has not made a distinction
16 between a Priority 1 versus a Priority 5, in other
17 words, the high priority or low priority.
18 Basically the bar, scientific bar has been set very
19 low, that any project that has scientific merit is
20 approved.
21 And while the criteria that you're
22 mentioning and the guidance in terms of relevance
0083
1 to clinical practice and so forth, may be part of
2 the discussion. They generally would only affect
3 the enthusiasm or that priority score ranking. It
4 wouldn't affect whether or not a project was
5 approved or disapproved.
6 JUDGE BITTNER: To receive NIDA marijuana.
7 THE WITNESS: To receive NIDA marijuana.
8 And anything that gets approved gets NIDA
9 marijuana. So it gets approved for NIDA marijuana
10 with high enthusiasm, medium enthusiasm or low
11 enthusiasm. It doesn't matter, they're all
12 approved to receive NIDA marijuana.
13 BY MR. HOPPER:
14 Q So is it your testimony then that these
15 guidelines, the written criteria that are referred
16 to here as priorities and conditions, that those
17 are supplemented by or--what's the appropriate
18 word? That there's an informal process that occurs
19 that isn't really reflected by the written
20 document?
21 A Can you--maybe you should tell me exactly
22 where you're looking in here.
0084
1 Q On page 2 of Government's Exhibit 24 at
2 Roman numeral heading II, Availability of Marijuana
3 for Research Purposes. "HHS has determined that it
4 will make research grade marijuana available on a
5 cost reimbursable basis subject to the priorities
6 and conditions described in Section 3 below."
7 Doesn't that suggest that HHS is going to
8 condition, NIDA's going to condition the provision
9 of marijuana to a researcher on the criteria that
10 are laid out there?
11 A Uh-huh.
12 Q And is what you're describing an informal
13 process that is more forgiving than the written
14 text of the document? I'm just trying to be sure I
15 understand your testimony.
16 A Can I have a minute just to read this, so
17 that I'll answer your question better?
18 Q Take as long as you need.
19 [Pause.]
20 THE WITNESS: Okay. Your question was
21 whether Section 3 here is used in to guide the PHS
22 review?
0085
1 MR. HOPPER: Yes.
2 THE WITNESS: Yes.
3 BY MR. HOPPER:
4 Q All right. Let me just turn then just to
5 some of the specific conditions and priorities that
6 are set out there to see if we can get a better
7 understanding of exactly what kind of research will
8 or will not be provided with marijuana. Do you see
9 that first full--or the second paragraph under that
10 Roman heading II?
11 A Uh-huh.
12 Q Second sentence beginning, "The goal of
13 this program must be to determine whether
14 cannabinoid components of marijuana." Can you just
15 read from that point through the end of that
16 paragraph? Not out loud, but just to yourself.
17 A Okay.
18 Q So isn't it true that according to this
19 announcement, the PHS review process is going to
20 strongly favor and in fact encourage research with
21 other than whole plant marijuana, in other words,
22 the cannabinoids and synthetics, the derivatives,
0086
1 and non-smoked delivery systems?
2 A I think that's the ultimate goal of the
3 program, yes.
4 Q I'm sorry. It's the ultimate goal of?
5 A Of the program.
6 Q Of the program. And isn't it true that
7 when the PHS Review Committee is reviewing a
8 research protocol, that one of the things they look
9 very closely at is whether the goals of the
10 research are consistent with the goals of the
11 program?
12 A Yes.
13 Q So would you agree then that a researcher
14 who was seeking to do research with the intent of
15 taking the whole plant marijuana, smoked or
16 vaporized, through the FDA approval process and
17 through the pharmaceutical development process, to
18 make it available as a prescription drug, would--
19 MS. PAREDES: Objection.
20 MR. HOPPER: I'm sorry.
21 JUDGE BITTNER: You can finish.
22 MR. HOPPER: Would have a very difficult
0087
1 time gaining approval from the PHS Review Committee
2 under the criteria that are delineated here in the
3 announcement?
4 THE WITNESS: Not at all. There's an
5 understanding that research with the crude plant
6 material is a necessary first step in demonstrating
7 proof and principle, if you will, before additional
8 research in purifying pharmaceuticals and
9 components of marijuana, and developing non-smokable and
10 alternative delivery devices could
11 occur. So there is a need for research on smoked
12 marijuana.
13 BY MR. HOPPER:
14 Q All right. But the--calling your
15 attention to that same paragraph that you just
16 read, the last sentence of that paragraph, "As the
17 IOM report stated, therefore, the purpose of
18 clinical trials of smoked marijuana would not be to
19 develop marijuana as a licensed drug, but such
20 trials could be a first step towards the
21 development of a rapid onset non-smoke cannabinoid
22 delivery system."
0088
1 Now, isn't that pretty clearly stating
2 that researchers with the goal of developing
3 marijuana as a licensed drug would have research
4 with the goal that is inconsistent with this
5 program?
6 A That's a question for FDA. It's not a
7 question for this program or for research on smoked
8 marijuana. And also, this is a comment by IOM,
9 it's not a comment of the PHS. I can clearly say
10 that there is a strong endorsement of this concept
11 within NIH and HHS that ultimately there's going to
12 be pharmaceuticals developed based on the
13 components of marijuana, that there will be
14 purified pharmaceuticals. They won't be in a
15 smoked product, and they'll probably develop to be
16 administered through alternative delivery devices.
17 Q I understand what you said, that
18 ultimately this is a question for the FDA. But
19 isn't it true that under the current system, with
20 NIDA having complete control over the provision of
21 marijuana for research, that there are research
22 protocols approved by the FDA to do research with
0089
1 whole-plant marijuana that are not provided with
2 marijuana under these guidelines? PHS with that
3 additional layer of review says no to research that
4 has been approved by the FDA. Isn't that true?
5 A Well, I have problems with--there is no
6 additional review, and I also take issue with your
7 characterization that NIDA has complete control
8 over the distribution of marijuana. Actually, NIDA
9 has very little control over who gets marijuana for
10 research purposes. It's based upon recommendations
11 of either an NIH peer review committee or the PHS
12 committee, for the most part.
13 Q I believe that you've testified, though,
14 and just to be clear, NIDA's marijuana, which can
15 be obtained only through an application by a
16 researcher to NIDA--
17 A I'm sorry. Go ahead.
18 Q I'm sorry, what--let me back up. I
19 thought you said there were four steps that someone
20 has to go through in order to obtain marijuana
21 through the NIDA program.
22 A Right.
0090
1 Q And that the fourth of those steps was the
2 submission of a form--
3 A Yes.
4 Q --to NIDA.
5 A Right.
6 Q That's the only way that a researcher--privately
7 funded, government funded, anywhere in
8 the United States--can get marijuana to do that
9 research. Isn't that true?
10 A Well, that--you're mischaracterizing the
11 fourth step. There are really three steps, the
12 first three things you mentioned.
13 Q Okay.
14 A There's an FDA IND process, there's a DEA
15 registration, and there's a scientific peer review.
16 The fourth--what you're characterizing as a fourth
17 step is simply a piece of paper, just the
18 paperwork. It's a way to administratively make it
19 happen. There has to be some kind of
20 administrative procedure, and that's the DEA Form
21 222 that's actually sent to the NIDA contractor.
22 So there's no decision at that point. There's no
0091
1 decision that NIDA makes at that point. There's
2 simply an order form.
3 Q Isn't it true that the only way that a
4 researcher in the United States can get marijuana
5 to do research is through this program that
6 provides marijuana that is under the control of,
7 grown under contract with, NIDA?
8 A Yes.
9 Q So unless a researcher is able to get
10 marijuana from NIDA through this program, that
11 researcher cannot do his or her research. Correct?
12 A Yes.
13 Q And this program you've described, I think
14 that we've established, sets up conditions and
15 criteria such that a researcher who has FDA
16 approval for a research protocol and who, if their
17 research were with any other controlled substance
18 than marijuana, could just get the controlled
19 substance and proceed with the research, can't
20 proceed with that research unless they get their
21 marijuana from NIDA. Isn't that right?
22 A Well, there's a few Schedule I substances,
0092
1 as I've said, are available from other sources, but
2 not "any" other Schedule I substance. And then,
3 yes, as I've described, there is a requirement for
4 a scientific review before any government resources
5 can be used--and in this case it's government-produced
6 marijuana can be provided to researchers.
7 So yes.
8 JUDGE BITTNER: Doctor, I have a feeling
9 we're back to being on parallel planes here.
10 Earlier, I think you took issue with something in
11 one of Mr. Hopper's questions referring to NIDA
12 approval, if I recall correctly, a few minutes ago.
13 Does NIDA have representatives that sit on the PHS
14 committee?
15 THE WITNESS: Yes.
16 JUDGE BITTNER: Who makes the decision as
17 to whether the product, the marijuana, will be
18 provided? Who actually says this guy gets it, this
19 guy doesn't?
20 THE WITNESS: It's a committee decision.
21 JUDGE BITTNER: The PHS committee?
22 THE WITNESS: Yes.
0093
1 JUDGE BITTNER: Okay, the director, the
2 deputy director and so on of NIDA do not sign off
3 on that? In other words, the committee is the
4 final authority?
5 THE WITNESS: Yes.
6 JUDGE BITTNER: And the people on the
7 committee are from where?
8 THE WITNESS: They're from NIH, FDA, and I
9 think there's been--I think SAMSA--I mean, SAMSA, I
10 know that three agencies that have been requested
11 to participate in this are the FDA, NIH, and SAMSA.
12 JUDGE BITTNER: Are they employees of
13 those components?
14 THE WITNESS: Yes. They are.
15 JUDGE BITTNER: They're not private
16 practitioners who are called in as--
17 THE WITNESS: No.
18 JUDGE BITTNER: --contractors or
19 representatives, like of the American Medical
20 Association or something like that?
21 THE WITNESS: No.
22 JUDGE BITTNER: Okay. Go ahead, Mr.
0094
1 Hopper.
2 MR. HOPPER: Thank you, Judge Bittner.
3 BY MR. HOPPER:
4 Q And just to clarify something you just
5 said, Dr. Gust, did you say that representatives
6 from those other government agencies have been
7 invited to participate on the PHS committee, or
8 actually participate currently? Is there someone
9 from FDA on the PHS Review Committee now?
10 A Yes. I believe so. Actually, I think
11 you'd better not quote me on that. I'm not exactly
12 sure who the members are.
13 JUDGE BITTNER: How big is the committee?
14 And does the committee sit for, like, a period of
15 time?
16 THE WITNESS: It's a group that is, that
17 meets as needed.
18 JUDGE BITTNER: Is it always the same
19 people, or--
20 THE WITNESS: No.
21 JUDGE BITTNER: --do they have specific
22 terms, or...?
0095
1 THE WITNESS: It's not--there's no
2 specific term of membership, it's more--people are
3 identified for their specific expertise, for a
4 specific protocol. If somebody has a protocol, for
5 example, to look at marijuana and pain, effects on
6 pain, there will be somebody from the National
7 Institute of Neurology on the committee.
8 JUDGE BITTNER: So it's a--
9 THE WITNESS: With cancer, it's sort of ad
10 hoc according to what the specific protocol is
11 about. But in general, there's from six to 10
12 members.
13 JUDGE BITTNER: Who appoints the members?
14 THE WITNESS: The PHS.
15 JUDGE BITTNER: Who in the PHS?
16 THE WITNESS: Pardon?
17 JUDGE BITTNER: Who in the PHS?
18 THE WITNESS: It's--there's an executive
19 chairperson of the committee.
20 JUDGE BITTNER: And that's a continuing
21 function?
22 THE WITNESS: Yes.
0096
1 JUDGE BITTNER: So this individual would
2 say, okay, this particular proposed research has to
3 do with--
4 THE WITNESS: Cancer pain or whatever.
5 JUDGE BITTNER: And therefore we need
6 somebody from--
7 THE WITNESS: Cancer Institute.
8 JUDGE BITTNER: Okay.
9 THE WITNESS: Neurology. Whatever.
10 JUDGE BITTNER: And then does this
11 chairman contact the prospective committee
12 members,or does the chairman call the director of
13 the Cancer Institute?
14 THE WITNESS: Both.
15 JUDGE BITTNER: Okay. Thank you. Go
16 ahead, Mr. Hopper.
17 MR. HOPPER: Thank you very much, Judge
18 Bittner.
19 BY MR. HOPPER:
20 Q Do you know--are you familiar with the
21 composition of the--well, let me just back up for a
22 second. I believe that your final answer to my
0097
1 last question was that you couldn't tell us whether
2 or not there's someone from the FDA on the PHS
3 committee?
4 A I know there has been in the past, I just--I can't
5 tell you currently if there is or not.
6 Q Do you know who was on the PHS Review
7 Committee that reviewed the Chemic Labs protocol
8 that was denied?
9 MS. PAREDES: Objection. Relevance.
10 JUDGE BITTNER: Overruled.
11 THE WITNESS: Do you want specific names
12 and members? I could give you a few names of
13 individuals.
14 BY MR. HOPPER:
15 Q Yes, if you could. I mean--
16 A I know the institutes. I know the
17 institutes that were represented were the National
18 Center on Complementary and Alternative Medicine,
19 the National Cancer Institute, the National
20 Institute of Neurology, NIDA. And one or two
21 others.
22 JUDGE BITTNER: Doctor, what's the
0098
1 difference between a center and an institute? If
2 there is one.
3 THE WITNESS: Prestige. No, centers are--there's
4 no real difference. NIH is comprised of
5 centers and institutes. They're sort of the same.
6 JUDGE BITTNER: I see. Somebody just
7 wanted to confuse the--
8 THE WITNESS: Yeah, right.
9 JUDGE BITTNER: Okay.
10 BY MR. HOPPER:
11 Q So no one from FDA, to your knowledge?
12 A I--quite honestly, I can't remember if
13 there was somebody from FDA. There may have been.
14 Q What department does the Public Health
15 Service chair for? I'm sorry, I didn't quite get
16 that.
17 A He's in the Office of the Secretary.
18 Q Office of the Secretary of HHS?
19 A Office of the Secretary of Health and
20 Human Services.
21 Q What's his name?
22 A Up to now, it's been Joel Eggertson.
0099
1 Q Mr. Eggertson is retired, is that it?
2 A Mr. Eggertson has recently retired, yes.
3 Q And you don't know who the replacement is?
4 A No.
5 Q So if I--I think that is very useful
6 information and I'm afraid it got me a little bit
7 off my main track. I want to try to get back to
8 that, which is that--and so forgive me if I'm
9 repeating a question. I'm sure that counsel for
10 the DEA will let us know if I am.
11 I'm trying to understand your earlier
12 response that a person who was seeking a researcher
13 or a research sponsor, seeking to do research with
14 marijuana, whole-plant marijuana, smoked marijuana,
15 with the stated goal an intent of that research
16 being to take whole-plant smoked marijuana through
17 the FDA approval process and make it available as a
18 prescription medicine, would be able to do that
19 under the criteria set out in this announcement.
20 Is it your testimony that a person seeking
21 to do that kind of research would not have a
22 problem getting marijuana from NIDA under the
0100
1 criteria laid out in this announcement? On the
2 basis that what they're trying to do is
3 inconsistent with the goals of the program?
4 A If they had an IND from FDA, I would say
5 they would not have a problem getting marijuana.
6 JUDGE BITTNER: And when you say, Mr.
7 Hopper, when you say a whole plant--again, I have a
8 certain naivete about marijuana in general. When
9 you refer to "whole-plant smoked marijuana," are
10 you referring to something akin to a marijuana
11 cigarette?
12 MR. HOPPER: Yes, Judge Bittner, I--
13 JUDGE BITTNER: In other words, a
14 prescription product that looks like a cigarette?
15 MR. HOPPER: Yes, or--
16 JUDGE BITTNER: And that you light and you
17 smoke?
18 MR. HOPPER: --rolled cigarette, but my
19 distinction is between the botanical plant and
20 cannabinoids that have been extracted or
21 synthesized in a lab.
22 JUDGE BITTNER: Okay. All right. That's
0101
1 a little different than what I meant, then.
2 MR. HOPPER: Well, I'm very glad that you
3 asked the question, then, because I think that--
4 JUDGE BITTNER: I guess what I'm asking
5 is, what sort of item is the consumer going to pick
6 up at the drugstore when the prescription is
7 filled? What will that thing look like?
8 MR. HOPPER: My understanding is that in
9 Canada, for instance, what it looks like is either
10 a rolled cigarette or a--what Dr. El Sohly referred
11 to as a "bud." Marijuana in a plastic package, as
12 he was describing that he was--he saw the Dutch
13 manufacturing plant.
14 JUDGE BITTNER: Okay, but it's actually
15 plant material?
16 MR. HOPPER: Right. Right, versus a--I'm
17 sorry.
18 JUDGE BITTNER: Versus a tablet or a
19 capsule that contains something that's made out of
20 plant material, or extracted from it?
21 MR. HOPPER: Precisely.
22 JUDGE BITTNER: Okay, so I guess the
0102
1 question is would someone who's intended goal was
2 to achieve FDA approval for such a product as a
3 prescription drug have more difficulty getting
4 marijuana from NIDA than would somebody who wants
5 to produce some sort of an extract. I don't know,
6 is that the question, Mr. Hopper?
7 MR. HOPPER: Yes.
8 JUDGE BITTNER: Okay.
9 THE WITNESS: I don't believe so.
10 JUDGE BITTNER: Okay.
11 THE WITNESS: I mean, that would be a
12 tough road to hoe--tough row to hoe to get there,
13 for sure. But that's not a question for the
14 research, it's a question for the approval process,
15 the regulation and approval process that goes on
16 through FDA. And I really can't comment on that.
17 JUDGE BITTNER: In other words, that's a
18 question as to whether or not this "stuff"--
19 THE WITNESS: Yeah.
20 JUDGE BITTNER: --could ever be safe,
21 effective, et cetera, as a prescription drug?
22 THE WITNESS: Yeah, I don't think there's
0103
1 any presumption that the ultimate goal of any
2 particular researcher looking at a product--or
3 looking at a research proposal, if the ultimate
4 goal is to have that, have the marijuana ultimately
5 approved as medicine or have an extract of
6 marijuana approved as medicine or have some
7 purified component of marijuana approved as a
8 medicine, does not significantly impact whether or
9 not that protocol is approved. In my view.
10 BY MR. HOPPER:
11 Q But by the FDA or by--
12 A No, by the PHS review--
13 Q By the PHS.
14 A The PHS Review Committee.
15 Q I just--I'm trying to understand. I just
16 want to read the sentence to you.
17 A Okay.
18 Q The goal of this program must be to
19 determine whether cannabinoid components of
20 marijuana administered through an alternative
21 delivery system can meet the standards enumerated
22 under Food, Drug, and Cosmetic Act for commercial
0104
1 marketing of a medical product, as the IOM report
2 stated. Therefore, the purpose of clinical trials
3 of smoked marijuana would not be to develop
4 marijuana as a licensed drug, but such trials could
5 be a first step toward the development of rapid
6 onset non-smoked cannabinoid delivery systems.
7 Isn't it true that that states, in pretty
8 strong terms, that the goal of the research must
9 be--
10 A That's the IOM's view. And I would say--as I
11 said, I think the HHS would strongly endorse
12 that, that ultimately, if there's going to be an
13 approved medication, it's going to be a purified
14 constituent of marijuana that will be delivered in
15 a non-smokable form. You know, and I think that's
16 certainly the strong preference. If you're asking
17 me if there's a bias towards the concept of
18 approving marijuana as a medication, I would say
19 not at the level of the PHS review--in my view, in
20 my experience.
21 Q But what you just referred to as a strong
22 bias, is that not expressed in very clear terms in
0105
1 this document, which sets out the conditions and
2 priorities under which PHS will approve protocols
3 to receive NIDA marijuana?
4 A It doesn't really set--what does it up
5 that--it simply is stating--I don't see how that
6 preempts--that's preempted in any way in terms of
7 what particular studies or what particular goals of
8 any particular study might be. I just don't see
9 that.
10 Q Well, wouldn't you agree that that
11 paragraph that we've just been looking at, where it
12 says "the goal of this program must be," doesn't
13 the "this program" refer to the program--NIDA's
14 provision of marijuana to researchers under the PHS
15 review process?
16 A I think--
17 MS. PAREDES: Objection. Asked and
18 answered.
19 JUDGE BITTNER: Overruled.
20 THE WITNESS: I think that is an ultimate
21 goal but that does not preempt any other studies
22 along the way.
0106
1 BY MR. HOPPER:
2 Q Okay. And isn't it true that a researcher
3 with FDA approval and DEA approval for their
4 research could still be denied access to NIDA
5 marijuana under the guidelines and conditions that
6 are set out here in the announcement?
7 A If they do not have scientific merit, then
8 it's true.
9 Q Right, if the PHS committee determines
10 that there's no scientific merit.
11 A That's correct.
12 Q And is it your testimony that the FDA,
13 then, by approving a protocol, hasn't evaluated the
14 scientific merit of the protocol?
15 A I don't--
16 Q So just turning your attention to the
17 third page of that announcement, Government's
18 Exhibit 24--do you have that page, Dr. Gust?
19 A Yes.
20 Q Okay. Roman numeral IV, heading
21 "Marijuana Trial Design Elements."
22 A Mm-hm.
0107
1 Q Third paragraph down. Doesn't that
2 sentence read, "FDA's primary objectives in
3 reviewing an IND are in all phases of the
4 investigation to assure the safety and rights of
5 subjects and in Phase 2 & 3 to help assure that the
6 quality of the scientific evaluation of drugs is
7 adequate to permit an evaluation of the drug's
8 effectiveness and safety. Therefore, FDA's review
9 of Phase 1 submissions will focus on assessing the
10 safety of Phase 1 investigations. FDA's review of
11 Phases 2 & 3 submissions will also include an
12 assessment of the scientific quality of the
13 clinical investigations and the likelihood that the
14 investigations will yield data capable of meeting
15 statutory standards for marketing approval."
16 Do you agree with that statement of FDA
17 objectives?
18 A I don't work at FDA, I'm not an expert on
19 FDA, so I can't comment on--I mean, it's written
20 there. As to whether or not it's accurate and
21 would reflect what FDA would say in this chair, I
22 can't answer that. I assume it was vetted and
0108
1 approved by them, but I have no personal knowledge
2 of that.
3 Q Well, just given your experience and the
4 work that you do for NIDA, is it your belief that
5 the FDA would approve a research protocol that had
6 no scientific merit?
7 A Well, I think the FDA generally, as is
8 stated here, reviews protocols for safety concerns.
9 And that's based upon the presumption that a drug
10 company would never put forward a compound to be
11 tested if it wasn't going to provide data that they
12 would be able to use to get ultimate drug approval.
13 And so...
14 Q Okay. What you just described is FDA
15 Phase 1 studies, right? Safety--
16 A That's what it says here, yeah.
17 Q Right. Phase 2 & 3, though, it says the
18 submissions will include an assessment of the
19 scientific quality of the clinical investigations.
20 Doesn't that indicate that the FDA, in its review
21 of research protocol for Phase 2 & 3 studies, is
22 evaluating the scientific merit of the research
0109
1 protocol?
2 A That's what it says, yes.
3 Q Just going back to this distinction that
4 Judge Bittner helped us clarify between what I've
5 been referring to as whole-plant marijuana versus
6 cannabinoids and extracts, isn't it true that an
7 example of a non-smoked cannabinoid delivery system
8 such as that given preference by the conditions and
9 priorities set out in the announcement, an example
10 of such a system would be the THC suppository
11 product that's being developed by Dr. El Sohly?
12 A Yes.
13 Q And isn't the FDA's stated position that
14 FDA is receptive to research into the medicinal
15 uses of botanical marijuana, not just cannabinoids
16 or synthetics?
17 A I don't know that.
18 Q Dr. Gust, if a privately funded researcher
19 wanted to conduct purely analytical and good lab
20 practice research--say, again, the example that I
21 gave you earlier, to measure the functionality of a
22 vaporizer machine designed to deliver cannabinoids
0110
1 from botanical marijuana--with the goal of
2 eventually facilitating FDA approval of botanical
3 marijuana using a vaporizer delivery system, isn't
4 it true that PHS would be unlikely to grant its
5 approval for marijuana--
6 A That's a PHS decision, actually. I mean,
7 anytime there's a--we defer to the PHS anytime I
8 get a request or an application for marijuana when
9 a decision needs to be made about whether or not
10 it's ultimately going to be of clinical relevance
11 and related to medical use of marijuana. So I
12 can't say that necessarily. Certainly there are
13 instances, and I think the proposal you're
14 referring to is one that was deemed to be
15 appropriate for review by the PHS committee, given
16 that it was going to be ultimately used, or the
17 goal was to use it in patients.
18 JUDGE BITTNER: Mr. Hopper, what would be
19 non-botanical marijuana?
20 MR. HOPPER: Dr. El Sohly's extract, the
21 THC extract, is non-botanical marijuana. Any of
22 the cannabinoids that have been isolated for--
0111
1 JUDGE BITTNER: But then they're no longer
2 marijuana, are they?
3 MR. HOPPER: That is a bit redundant,
4 isn't it?
5 JUDGE BITTNER: It seems so, unless it's--perhaps
6 it's just for emphasis. Okay.
7 MR. HOPPER: Not at all. I'm open to
8 suggestions about a better way to make that
9 distinction. I'm merely trying to distinguish
10 between the synthetics and the extracts versus the
11 whole plants.
12 JUDGE BITTNER: Right. Okay. I got you.
13 MR. BAYLY: Your Honor, may I comment?
14 Just to make things clear, the problem is synthetic
15 is really part of a marijuana, it's synthetic.
16 JUDGE BITTNER: Right.
17 MR. BAYLY: And yet you can extract from
18 the marijuana different cannabinoids and I don't
19 think we would characterize them as synthetic.
20 JUDGE BITTNER: Right. I think I
21 understand. We'll hope that I do, since we don't
22 want me to be confused. Now I'm okay. I've got
0112
1 it. It's just the "botanical" that got me
2 confused. Somehow it's easier if you say "plant."
3 I'm thinking, well, maybe there's a fake marijuana,
4 plastic marijuana.
5 Okay, go ahead, Mr. Hopper.
6 MR. HOPPER: Thank you. Thank you, Mr.
7 Bayly.
8 BY MR. HOPPER:
9 Q Just a few more questions here, Dr. Gust.
10 So you've testified that NIDA has a
11 contract with Dr. El Sohly and the University of
12 Mississippi to cultivate marijuana for research.
13 Right?
14 A Yes.
15 Q But NIDA does not license Dr. El Sohly or
16 the University of Mississippi to permit them to
17 cultivate. Is that right?
18 A Right.
19 Q No license from NIDA.
20 A Correct.
21 Q And isn't it the DEA that's the government
22 entity that's responsible for licensing them to
0113
1 cultivate, do the very same process that Dr. Craker
2 filed an application seeking his own registration?
3 A That's my understanding.
4 Q And as part of that licensing process, is
5 it your understanding that DEA sends someone out to
6 inspect the facility where the marijuana's going to
7 be grown and the space where it's going to be
8 cultivated is adequate and secure?
9 A I have no--I don't know. I don't know
10 exactly what they do.
11 Q Okay. NIDA doesn't do that, do they?
12 A No.
13 Q And the same is true--I'm sorry. Dr. El
14 Sohly has two sort of non-NIDA registrations, and
15 the same is true with both of those, right? Your
16 answer is in terms of NIDA doesn't license them,
17 NIDA doesn't inspect the facilities, NIDA doesn't
18 evaluate security--
19 A Certainly not.
20 Q --for anything outside the NIDA contract?
21 A Correct.
22 Q And it's DEA, again, not NIDA that does
0114
1 the licensing for Dr. El Sohly to engage in his
2 activities? I'm sorry, you said that you weren't
3 sure.
4 A As far as I know.
5 Q Okay. And isn't it the DEA and not NIDA
6 that sets quotas on the quantities that can be
7 grown under the non-NIDA licenses?
8 A I don't know who sets--I know there are
9 quotas, and those are established under the, some
10 of the international treaties. I'm not sure how--who
11 monitors that and--
12 Q But--I'm sorry. But it's not NIDA? Is
13 that right?
14 A It's not NIDA.
15 MR. HOPPER: Your Honor, could we take
16 another 15-minute break, and then I think we are
17 about done.
18 JUDGE BITTNER: Okay. Fifteen minutes.
19 Off the record.
20 [Recess.]
21 JUDGE BITTNER: On the record.
22 Mr. Hopper.
0115
1 MR. HOPPER: Thank you.
2 BY MR. HOPPER:
3 Q Dr. Gust, really, just a couple more
4 questions, I promise.
5 JUDGE BITTNER: They all say that, Doctor.
6 MR. HOPPER: This time it's true.
7 BY MR. HOPPER:
8 Q You testified, Dr. Gust, didn't you, that
9 there are other Schedule I drugs beyond marijuana
10 for which NIDA is the sole source? Is that
11 correct?
12 A Yes.
13 Q But isn't it true that there no
14 requirement as to any of those other drugs that
15 NIDA be the sole source?
16 A I don't know the answer to that.
17 Q Are you aware of any requirement that NIDA
18 be the sole source for any of those other drugs?
19 A No.
20 Q With regard to the PHS review process that
21 we've been talking about, once a protocol has been
22 denied or rejected, disapproved, by the PHS Review
0116
1 Committee, is there any kind of an appeal process
2 available to a researcher?
3 A The general practice of the committee has
4 been that no project is disapproved. It's
5 generally the deficiencies and weaknesses in the
6 proposal are pointed out to the researcher and the
7 approval is denied until such time as those changes
8 are made and protocols are revised and resubmitted
9 and re-reviewed. It's been the general way that
10 the committee has operated.
11 JUDGE BITTNER: And, I'm sorry, this is
12 the PHS committee?
13 THE WITNESS: The PHS committee.
14 BY MR. HOPPER:
15 Q And is it your understanding that that is
16 going to continue to be the procedure?
17 A Yes, my understanding is that that will
18 continue.
19 Q And with regard to the Chemic application
20 that we talked about, if I told you--are you aware
21 that a letter has been sent from Chemic to the PHS
22 Review Committee rebutting the rationale for PHS
0117
1 having denied its application?
2 A No.
3 Q If I told you that Chemic has sent such a
4 letter, then would it be your understanding that
5 the PHS review will continue and that the PHS
6 Review Committee will take into account the letter?
7 A Yes.
8 Q And can you tell us--do you know if it's
9 the same PHS Review Committee, it's the same
10 people, that will be conducting this continued
11 review as the committee that denied the initial
12 application?
13 A Generally, yes. I mean, there is some
14 turnover as employees perhaps leave the government
15 and so forth, but in general it tends to be the
16 same individuals, yes.
17 Q You testified earlier that your
18 understanding is that generally the time period for
19 review is about three to six months, although
20 there's no time limit. Is that correct?
21 A Yes.
22 Q Can you tell us, then, based on your
0118
1 understanding of the way the system works and
2 familiarity with Chemic's application, when Chemic
3 might expect to hear again from the committee?
4 A Without any additional information, I
5 would say between three and six months.
6 Q Three to six months from the time that the
7 committee received that subsequent communication?
8 A Mm-hm.
9 Q Do you know, Dr. Gust, is there any way
10 for a researcher or for the general public to
11 obtain from PHS the names of, the identity of the
12 people who are actually conducting the peer review
13 of their protocols?
14 A Am I aware of any way that researchers can
15 get those names? No, I'm not.
16 Q Do you know if a research were to request
17 from PHS the names of the committee members who had
18 reviewed that research's protocol, would that
19 information be provided?
20 A I would think so, but I don't know for--I
21 don't know. I would think so.
22 Q And Dr. Gust, you testified, I believe--I
0119
1 just want to make sure I have this clear--that the--well,
2 you testified that there are these two forms
3 of NIH review, actually three forms of NIH review.
4 One is when you apply for funding from NIH, and
5 then the other is the PHS review we've been talking
6 about, and then there's a third ad hoc review that
7 takes place for, I think you said, non-human,
8 animal-type studies? Is that accurate?
9 A Yeah, I would say exactly that and
10 probably also other types of studies that were
11 conducted in humans but were not related to medical
12 applications of marijuana.
13 Q Okay. And was it your testimony that the
14 ad hoc review that takes place, that those reviews
15 are undertaken by non-government employees for the
16 most part, that those are people from the non-government
17 community?
18 A Yes.
19 Q And the PHS Review Committee that you've
20 described to us, that is all government employees.
21 Is that correct?
22 A That's correct.
0120
1 Q But I think you also testified that even
2 the PHS Review Committee is ad hoc in that it is
3 not a standing committee comprised of the same
4 people, but rather those committees are formed on
5 an ad hoc basis depending upon the nature of the
6 protocol that's been submitted. Is that correct?